Body & Beauty / Compounds / Stearic Acid

Stearic Acid on your skin: a safety profile

Low risk

(People-specific data is limited; this page draws from human adult context.) Stearic acid (CAS 57-11-4) presents a low risk to human adults — among the lowest risk pharmaceutical excipients and food ingredients. FDA GRAS status as a direct food ingredient, EFSA well-established safety, and the fact that stearic acid is an abundant endogenous fatty acid in human physiology collectively support a very low risk characterization. Dietary stearic acid from animal and vegetable fats represents an exposure several orders of magnitude higher than pharmaceutical excipient doses, with no established adverse health effects at typical dietary intakes. Uniquely favorable cardiovascular profile among saturated fatty acids (neutral LDL effect). No contact sensitization concern. No systemic toxicity at pharmaceutical or food additive dose levels.

What is stearic acid?

The IUPAC name is octadecanoic acid.

Also known as: octadecanoic acid, n-Octadecanoic acid, Stearophanic acid, Stearex Beads.

IUPAC name
octadecanoic acid
CAS number
57-11-4
Molecular formula
C18H36O2
Molecular weight
284.5 g/mol
SMILES
CCCCCCCCCCCCCCCCCC(=O)O
PubChem CID
5281

Risk for people

Low risk

Stearic acid (CAS 57-11-4) presents a low risk to human adults — among the lowest risk pharmaceutical excipients and food ingredients. FDA GRAS status as a direct food ingredient, EFSA well-established safety, and the fact that stearic acid is an abundant endogenous fatty acid in human physiology collectively support a very low risk characterization. Dietary stearic acid from animal and vegetable fats represents an exposure several orders of magnitude higher than pharmaceutical excipient doses, with no established adverse health effects at typical dietary intakes. Uniquely favorable cardiovascular profile among saturated fatty acids (neutral LDL effect). No contact sensitization concern. No systemic toxicity at pharmaceutical or food additive dose levels.

Regulatory consensus

3 regulatory and scientific bodies have classified Stearic Acid. The classifications differ — that's the data.

AgencyYearClassificationNotes
US FDA / EFSA (Stearic acid — octadecanoic acid — FDA GRAS (21 CFR 184.1090 — direct human food ingredient, affirmed as GRAS; also 21 CFR 172.860 — fatty acids); FDA-approved pharmaceutical excipient (inactive ingredient database; oral, topical, vaginal routes — tablet lubricant, binder, coating component, cream/ointment ingredient); EFSA: stearic acid is an endogenous saturated fatty acid present in food; no specific numerical ADI — safety well-established from dietary exposure; no carcinogenicity classification by IARC, NTP, US EPA, or EFSA; neutral metabolic effects on LDL cholesterol distinguishing it from other saturated fatty acids; widely present in animal fats (beef tallow, cocoa butter) and some plant oils)2020no carcinogenicity classification; FDA GRAS; FDA-approved excipient; endogenous fatty acid with extensive dietary safety history; neutral LDL cholesterol effect; not classified by IARC, NTP, or EPA for carcinogenicity
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 3 positive / 3 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 3 positive / 3 negative reports)

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where you encounter stearic acid

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles
  • Consumer Products — dietary supplements, fortified foods, energy drinks
  • Fragrance — perfume, cologne, scented personal care products, household fragrance products, candles
    Identified in Fragrance Ingredient Safety Priority Research database (2,325 ingredients)

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Stearic Acid:

  • Fragrance-free formulations
    Trade-offs: Consumer preference for scented products
    Relative cost: Lower (ingredient elimination)
  • Essential oil-based fragrances (with disclosure)
    Trade-offs: Natural does not mean safe — many essential oils are skin sensitizers
    Relative cost: 2-5× conventional

Frequently asked questions

What products contain stearic acid?

Stearic Acid appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); dietary supplements (Consumer products).

Why do regulators disagree about stearic acid?

Stearic Acid has been classified by 3 agencies including US FDA / EFSA (Stearic acid — octadecanoic acid — FDA GRAS (21 CFR 184.1090 — direct human food ingredient, affirmed as GRAS; also 21 CFR 172.860 — fatty acids); FDA-approved pharmaceutical excipient (inactive ingredient database; oral, topical, vaginal routes — tablet lubricant, binder, coating component, cream/ointment ingredient); EFSA: stearic acid is an endogenous saturated fatty acid present in food; no specific numerical ADI — safety well-established from dietary exposure; no carcinogenicity classification by IARC, NTP, US EPA, or EFSA; neutral metabolic effects on LDL cholesterol distinguishing it from other saturated fatty acids; widely present in animal fats (beef tallow, cocoa butter) and some plant oils), EPA CTX / Genetox, EPA CTX / Genetox, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.

See Stearic Acid in the body app

Look up products containing stearic acid, compare to alternatives, and explore the full data record.

Open in body View raw API data

Sources (1)
  1. FDA GRAS 21 CFR 184.1090 Stearic Acid Direct Food Ingredient; FDA 21 CFR 172.860 Fatty Acids; Pharmaceutical Excipient Tablet Lubricant Binder; LDL Cholesterol Neutral Effect Desaturation to Oleic Acid; Endogenous Dietary Fatty Acid; No IARC NTP EPA EFSA Carcinogenicity Classification (2020) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →